FSVP Inspections Are Underway—Is Your Foreign Food Supplier Ready?

According to the FDA, the United States imports about 15% of its food supply. More than 200 countries and about 125,000 food facilities and farms supply 32% of the vegetables, 55% of the fruit, and 94% of the seafood that Americans consume annually. Imported food can be hazardous, picking up harmful contaminants along its journey to the States. During a testing period between 1996 and 2014, 195 outbreaks were attributed to imported food, resulting in 10,685 illnesses, 1,017 hospitalizations, and 19 deaths, according to the Centers for Disease Control (CDC).

To combat foreign foodborne illnesses, the U.S. government recently introduced regulations to hold importers accountable for what is brought into the United States and sold to American consumers: The Foreign Supplier Verification Program (FSVP).

Below, we examine the FSVP and what U.S.-based importers need to know to consistently and effectively ensure compliance.


As part of the Food Safety Modernization Act (FSMA), which was introduced by the Obama administration in 2011 to regulate how foods are grown, harvested, processed, and imported, the FSVP mandates that foreign suppliers of human and animal foods adhere to the levels of safety and quality required by the FSMA’s rule on preventive controls. This rule ensures domestic and foreign food facilities address issues related to reducing or eliminating food safety hazards.

FSVP compliance dates are already underway, though deadlines differ according to considerations like the size of the foreign supplier, the nature of the importer and whether the foreign supplier has met their own unique requirements. Detailed requirements can be found in the FDA’s list, “Compliance Dates for the Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals.”


U.S.-based importers should prepare for and maintain compliance by studying their inspection processes. FSVP inspections are based on the review of records (verification documents, sampling processes, and records), testing results, and supplier audit procedures and findings.

These records should always be available and organized for regulatory inspections, most of which will take place in-person at the importer’s place of business. That said, the inspections could occur electronically to ensure prompt responses to inquiries.

For any detected record deficiencies, the importer will initially be allowed to correct them. The FDA’s focus of the program is to support compliance in its beginning stages unless problems reflect a danger to the public’s health or an intentional disregard for legal responsibilities. However, while there is a grace period (which varies according to the compliance deadline considerations), the consequences of long-term noncompliance range from significant fines to mandatory recalls.


While most compliance dates have already passed, many importers still rely on manual processes that limit their ability to keep track of supplier data. To effectively maintain compliance, importers can take advantage of food safety management system (FSMS) software through integrations with quality management system (QMS) solutions which help automate, integrate, and standardize food safety quality and compliance processes. Adopting an integrated FSMS – QMS will streamline FSVP inspections by:

  • Automating record-keeping: If an employee can immediately pull up any piece of information requested, FDA inspectors will clearly note organization and preparedness for compliance.

  • Proactively managing suppliers: Integrated supplier QMS tools allow organizations to centralize records related to foreign suppliers. These include materials, testing and sampling records, audit findings, and corrective actions.

  • Conducting a mock inspection: To ensure preparation for FSVP inspections, organizations can stage a mock inspection for the specific foods that may be reviewed via FSMS software. Staging an inspection may not answer all FDA questions, but the run-through could identify pain points that need to be addressed.

With proper planning and open communication about current efforts to better protect consumer safety, food and beverage businesses can limit foodborne illnesses from domestic and foreign products. Now is the time to make food safety management and quality management a priority.

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